Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

April 21, 2022 updated by: Pentax Medical
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.

At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.

This study is:

  • Prospective
  • Multi-center
  • Non-randomized

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center Amsterdam
      • Nieuwegein, Netherlands
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Criteria Inclusion Criteria

  • Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
  • Patient is 18 to 80 years of age at the time of consent (inclusive).
  • Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
  • Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
  • Patient is deemed operable per standard institutional criteria.
  • BE lesion length <6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
  • One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
  • BE lesion within the treatment zone should be flat

Exclusion Criteria

  • Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
  • Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
  • Patient refuses or is unable to provide written informed consent.
  • Patients that are pregnant.
  • Patient with endoscopically active inflammation in the treatment zone.
  • Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C2 CryoBalloon Focal Ablation System
Cryoballoon ablation will be performed on patients with Barrett's Esophagus.
Device: C2 CryoBalloon Focal Ablation System

The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.

Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.

Evaluations include, but are not limited to the following:

  • Device malfunctions
  • Adverse events
  • Patient Pain
  • Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of residual Barrett's Esophagus
Time Frame: 12 weeks
Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 12 weeks
All adverse events will be reported
12 weeks
Patient Pain
Time Frame: post-procedure through 12 week follow-up
Patient is asked to rate any pain in the treatment area or with swallowing
post-procedure through 12 week follow-up
Device Performance
Time Frame: 12 weeks
All device performance will be reported
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pentax Medical

Investigators

  • Principal Investigator: Jacques Bergman, MD, PhD, Academic Medical Centre (Amsterdam)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 29, 2016

Study Completion (Actual)

October 4, 2017

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-0004.A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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